
Record of Telephone Conversation, July 15, 2011 - MenHibrix

 
RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA    Submission ID: 125363/0    Office: OVRR

Product:

Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine

Applicant:

GlaxoSmithKline Biologicals

Telecon Date/Time: 15-Jul-2011 11:45 AM        Initiated by FDA? Yes

Telephone Number: jody.a.gould@gsk.com, norris.h.pyle@gsk.com

Communication Categorie(s):

1. Advice

 

Author: KIRK PRUTZMAN

Telecon Summary:

CBER concurrance with quarantined lots and diluent inspection protocol

FDA Participants: KIRK PRUTZMAN, DAVID STATEN, JOSEPH TEMENAK

Non-FDA Participants: JODY GOULD, NORRIS PYLE

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

Telecon Body:

Dear Dr. Gould,

 

CBER has discussed your proposed Manual Visual Inspection protocol and your proposed shipping of quarantined lots of MenHibrix bulk conjugate. 

 

Regarding the issues of the Manuel Visual Inspection for the diluent for Menhibix, CBER concurs with your proposed inspection plan in your email dated July 14, 2011. 

 

Regarding your questions about sending bulk conjugate lots under quarantine proposed in an email dated July 11, 2011, CBER accepts these lots. You may ship them as soon as they are ready.   

 

Regards,

 

Kirk Prutzman, PhD

Food and Drug Administration

Primary Reviewer/Regulatory Project Manager

CBER/OVRR/DVRPA/CMC3

1451 Rockville Pike (WOC2)

Room 2241

HFM-481

Rockville, MD 20857

Phone: (301) 796-2640